Real World Evidence of Tivozanib as First-line Treatment for Metastatic Clear Cell Renal Cell Carcinoma

NCT07354282 | Completed

• 1 other identifier: SOGUG-2024-IEC(REN)-1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 14

Brief Summary

The SOGUG-TIVOREAL study is a retrospective observational study with medications. This study is based on the retrospective collection of data from patients who have been treated with Tivozanib as first-line therapy between 03/01/2019 and 08/31/2024 for metastatic renal cell carcinoma (mRCC).

Conditions

Renal Cell Cancer Metastatic

Keywords

Tivozanib

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  To evaluate the progression-free survival (PFS) in patients with metastatic clear cell renal cell carcinoma (mRCC) from the favorable risk group according to IMDC, treated with Tivozanib monotherapy as first-line therapy. The probability of progression-free survival will be described using the Kaplan-Meier method, along with the 95% confidence intervals of the point estimates, as well as the median time of survival from the start of treatment with Tivozanib until tumor progression or death from any cause, whichever occurs first. RECIST 1.1

  Day 1

Secondary Outcomes (8)

• Overall survival (OS) in favorable risk group

  Day 1

• Objective response rate (ORR) in favorable risk group

  Day 1

• Percentage of patients with PR and CR in favorable risk group

  Day 1

• Progression-free survival (PFS) - Intermediate and poor risk group

  Day 1

• Overall survival (OS) - Intermediate and poor risk group

  Day 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population of this study consists of patients diagnosed with metastatic renal cell carcinoma (mRCC) who initiated first-line treatment with Tivozanib between March 1, 2019, and August 31, 2024.

You may qualify if:

• \- Patients ≥ 18 years old.
• \- Histological diagnosis of stage IV clear cell renal carcinoma.
• \- Who started treatment with Tivozanib as first-line therapy between March 1, 2019, and August 31, 2024.
• \- Who received treatment at the participating center.

You may not qualify if:

• \- Patients previously treated at another center who were later referred to one of the participating centers. In this case, the patient will be included in the center where the treatment was initiated.
• \- Explicit objection by the subject or their legal representative to participate in the study.

Sponsors & Collaborators

• Spanish Oncology Genito-Urinary Group: lead
• Adknoma Health Research: collaborator

Study Sites (14)

Hospital Reina Sofia

Córdoba, Andalusia, Spain

Location

Hospital Virgen de la Victoria

Málaga, Andalusia, Spain

Location

Hospital Virgen del Rocio

Seville, Andalusia, Spain

Location

Hospital de Burgos

Burgos, Castille and León, Spain

Location

Hospital de Leon

León, Castille and León, Spain

Location

Hospital Vall de Hebron

Barcelona, Catalonia, Spain

Location

Institut Català d'Oncologia (ICO) de L'Hospitalet de Llobregat

L'Hospitalet de Llobregat, Catalonia, Spain

Location

Hospital Parc Tauli

Sabadell, Catalonia, Spain

Location

Hospital Lucus Augusti

Lugo, Galicia, Spain

Location

Hospital Severo Ochoa

Leganés, Madrid, Spain

Location

Fundacion Jimenez Diaz

Madrid, Madrid, Spain

Location

Hospital Gregorio Marañon

Madrid, Madrid, Spain

Location

Hospital Puerta de Hierro

Majadahonda, Madrid, Spain

Location

Instituto Valenciano de Oncologia (IVO)

Valencia, Valencia, Spain

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: January 21, 2026
• Study Start: May 13, 2025
• Primary Completion: August 7, 2025
• Study Completion: August 7, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (14)